The randomized clinical trial is now considered by many to be the goal standard among clinical trials. Non-randomized treatment comparisons are generally not considered credible, regardless of the rigor of the study design. Given this fact, it is surprising that no commercial standard products have been developed to address this need. A computer-based system is ideally suited to provide on-demand treatment allocations taking into account complex randomization methodologies including all previous allocations. No pre-printed allocations stored in sealed envelopes can meet these requirements. The relatively low cost of powerful personal computers now make it possible to develop inexpensive systems that provide immediate allocation to a treatment arm. Allocation can be made 24 hours a day via voice recorded scripts on a touch-tone telephone; or via a direct dial-in connection to the randomization computer; or via the Internet. By drawing upon the experience of its staff in the successful implementation of several computer-based randomization system, NERI is well-suited to develop this commercial product with it potential to be a key component of quality research. Specific task in Phase I include selecting software tools; coding the prototype; and testing the working prototype. PROPOSED COMMERCIAL APPLICATION: A dependable randomization system is a key component of quality research. Many organizations conduct studies where randomization is a critical factor to their success. These include contact research organizations, universities, government agencies, managed care providers and the pharmaceutical industry.